The European Commission Directorate-General for Communications Networks, Content and Technology (DG CNECT) has created a mhealth working group to develop guidelines for assessing the validity and reliability of data collected and processed by health apps. EFA is a member of the mHealth assessment guildelines working group that involves research institutes, associations and NGOs, private companies as well as national public authorities.
The working group met for the first time on the 8th of March in Brussels to discuss how mHealth guidelines could be used and decided that health apps falling under the medical legislation would not be addressed by the resulting guidelines. The guidelines would rather deal apps that could fall in the medical device definition but are not there yet.
The mHealth guidelines working group will investigate the issues not covered under the medical devices legislation but that could be relevant in the context of these guidelines. It will also map all stakeholder to identify user groups.
To know more about mHealth please visit EFA dedicated ehealth section.